BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3T

    MDR report key: 5655569 · Received May 16, 2016

    Report

    Report Number
    5655569
    Event Type
    Malfunction
    Date Received
    May 16, 2016
    Date of Event
    December 31, 2014
    Report Date
    May 6, 2016
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT 2 OPEN HEART SURGERY PROCEDURES DURING WHICH TIME A SORIN HEATER-COOLER SYSTEM WAS USED INTRAOPERATIVELY. EIGHT WEEKS LATER, AN AFB BLOOD CULTURE WAS COLLECTED AND M CHIMAERA WAS IDENTIFIED ABOUT 3 WEEKS LATER. THIS FACILITY IS UNABLE TO CONFIRM THAT THE NTM INFECTION CAN BE DIRECTLY RELATED TO THE USE OF THE SORIN HEATER-COOLER SYSTEM.

    Description of Event or Problem · 1

    PATIENT UNDERWENT 2 OPEN HEART SURGERY PROCEDURES ABOUT 2 YEARS AGO DURING WHICH TIME A SORIN HEATER-COOLER SYSTEM WAS USED INTRAOPERATIVELY. FOURTEEN MONTHS LATER, AN AFB BLOOD CULTURE WAS COLLECTED AND M. CHIMAERA WAS IDENTIFIED ABOUT 3 WEEKS LATER. THIS FACILITY IS UNABLE TO CONFIRM THAT THE NTM INFECTION CAN BE DIRECTLY RELATED TO THE USE OF THE SORIN HEATER-COOLER SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312075 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC SORIN GROUP USA, INC. 3T

    Patients

    Seq Age Sex Outcome Treatment
    1